An open label, long term, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia Syndrome - LCQ908 extension study

ovartis0 个研究点目标入组 9 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•1. Written informed consent
•2. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212

•1. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events
•2. Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure)
•3. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is * 8.5%.
•4. Treatment with fish oil preparations within 4 weeks prior to randomization
•5. Treatment with bile acid binding resins (i.e. colesevelam etc) within 4 weeks prior to randomization
•6. Treatment with fibrates within 8 weeks prior to randomization.
•7. eGFR < 45 ml/min/1.73m2 or history of chronic renal disease
•8. Glybera [alipogene tiparvovec (AAV1-LPLS447X)] gene therapy exposure within two years prior to screening
•9. Pregnant or nursing (lactating) women.
•10. Women of child-bearing potential not using highly effective methods of contraception during dosing and for 100 days after discontinuation of investigational study drug.

发起方